Senior Manager, Pharmacovigilance (Deputy QPPV)

Senior Pharmacovigilance Manager (Deputy QPPV)

• QPPV  qualifications to lead PV projects.
• Project management- managing client projects, including managing client relationships and project budgets.
• Review, quality control, and submissions of Individual Case Safety Reports (ICSR’s) to clients/ client partners and/or regulatory agencies.
• Preparing ICSR files for 3^rd party review including adjudication and review by Drug Safety Monitoring Boards.
• Conducting audits or gap analysis of client pharmacovigilance systems including regulatory agency inspections and client and internal audits.
• Providing training in pharmacovigilance legislation, regulations and industry best practices to colleagues and clients.

• B.Sc. or advanced degree in in Health Sciences or registered nurse or equivalent relevant experience and training.
• Extensive experience working within a pharmacovigilance environment including knowledge of ICH, EEA Good Pharmacovigilance Practices (GVP), European legislation  and regulatory guidance
• Excellent project management skills are required, as is the ability to effectively manage multiple simultaneous projects.
• Strong people skills, ability to manage people, time and resources while developing a supportive team environment
• The ability to interact with clients, to adapt to their priorities, and while providing strategic direction is essential.
• Strong command of the English language coupled with fluency in local language.